Genetically Modified Organisms

BCS-GH811-4

EU register of genetically modified food and feed.

Event GHB811
Authorisation holder Name BASF Agricultural Solutions Seed US LLC
Authorisation holder Address 100 Park Avenue, Florham Park, New Jersey 07932, United States,
represented in the Union by: BASF SE, Carl-Bosch-Str. 38, D-67063, Ludwigshafen, Germany.
Products (1) foods and food ingredients containing, consisting of or produced from genetically modified cotton BCS-GH811-4;
(2) feed containing, consisting of or produced from genetically modified cotton BCS-GH811-4;
(3) products containing or consisting of genetically modified cotton BCS-GH811-4 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Designation The genetically modified cotton BCS-GH811-4 expresses the hppdPfW336-1Pa gene, which confers tolerance to HPPD inhibiting herbicides and the 2mepsps gene, which confers tolerance to glyphosate based herbicides.
Labelling For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the 'name of the organism' shall be 'cotton';

The words 'not for cultivation' shall appear on the label of and in the accompanying documents of the products containing or consisting the maize specified with their unique identifiers, with the exception of foods and food ingredients.
Method for detection - Event specific real-time quantitative PCR based method for detection of the genetically modified cotton BCS-GH811-4.

- Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations
Reference material Reference Material: ERMĀ®-BF442 is accessible via the Joint Research Centre (JRC) of the European Commission at https://crm.jrc.ec.europa.eu/
Unique identifier BCS-GH811-4
Annex II to the Cartagena Protocol Biosafety Clearing-House
https://bch.cbd.int/en/database/DEC/BCH-DEC-EU-263225/1
Conditions or restrictions on the placing on the market Not required
Post-market monitoring requirements Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Date of authorisation 01/04/2022
Legal base Commission Decision (EU) 2022/530 of 31 March 2022
Authorisation expiration date 31/03/2032
Further information on risk assessment Opinion of the European Food Safety Authority:
https://doi.org/10.2903/j.efsa.2021.6781
Version: 1.1.3